Labetalol Hydrochloride
- Product NDC
- 55154-8192
- 11-digit product format
- 551548192
- Labeler code
- 55154
- Product ID
- 55154-8192_9be82c15-a0ba-4f52-8e76-6700731db35e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Labetalol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA207743
- Marketing category
- ANDA
- Marketing start
- 2019-07-16
- Substance
- LABETALOL HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Labetalol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LABETALOL HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1GEV3BAW9J |
| Rxcui | 896758, 896762 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-8192-0 | Labetalol Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 5 |
| 55154-8192-0 | Labetalol Hydrochloride | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-8192 | LABETALOL HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250427_63db5b00-e864-4b2d-84f2-00bf35211b9b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-8192-0 | 55154819200 | 10 BLISTER PACK in 1 BAG (55154-8192-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2019-07-16 | 0000-00-00 | No | No | Current |